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Treatment of Disseminated High Grade Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00536393
Recruitment Status : Completed
First Posted : September 27, 2007
Last Update Posted : November 1, 2007
Information provided by:
French Innovative Leukemia Organisation

Brief Summary:
Interest of the use of pegylated liposomal doxorubicin (caélyx)

Condition or disease Intervention/treatment Phase
Lymphoma Drug: Doxorubicin Drug: Doxorubicin pegylated Phase 2 Phase 3

Detailed Description:
R CHOP is a good standard in the treatment of diffuse high grade lymphoma. Howeverin elderly patients it is often toxic, specially with haematologic and cardiac toxicities.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Study of Treatment of Disseminated and Agressive Lymphoma R CHOP Versus R CLOP( With Liposomal Doxorubicin)
Study Start Date : October 2000
Study Completion Date : October 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Doxorubicine
CHOP 8 courses every 21 days
Drug: Doxorubicin
Experimental: Doxorubicine pegylated
CLOP 8 courses every 21 days
Drug: Doxorubicin pegylated

Primary Outcome Measures :
  1. hematologic toxicity [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. response rate [ Time Frame: 6 months ]
  2. EFS and OS [ Time Frame: 6 months ]
  3. Cardiac toxicity [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • high grade lymphoma
  • disseminated
  • > 60 years old and < 75
  • informed consent signed
  • cardiac state compatible with antracyclin
  • ECOG </= 2

Exclusion Criteria:

  • patients > 75 years old
  • Cardiac insufficiency

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00536393

Clinique Victor Hugo
Le Mans, France, 72015
Sponsors and Collaborators
French Innovative Leukemia Organisation
Principal Investigator: Guillaume CARTRON, Dr French Innovative Leukemia Organisation

ClinicalTrials.gov Identifier: NCT00536393     History of Changes
Other Study ID Numbers: GOELAMS 0804
First Posted: September 27, 2007    Key Record Dates
Last Update Posted: November 1, 2007
Last Verified: September 2007

Keywords provided by French Innovative Leukemia Organisation:
diffuse larg cells lymphoma
diffuse high grade lymphoma

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action